Pilot Study for High Output Drainage Removal After Gastrectomy

Not Applicable

Recruiting

• Conditions: Gastric Cancer

• Registration Number: NCT06690112
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

\*Objective: The study aims to evaluate whether there is a difference in intra-abdominal complication rates between patients discharged with or without a drainage tube following gastrectomy with high postoperative drainage (≥300ml/day).

\*Study Design: This is an open-label randomized controlled trial (RCT) involving two groups. Patients will be randomly assigned to either maintain the drainage tube (control) or have it removed (experimental) before discharge. The primary endpoint is the incidence of intra-abdominal complications within one month post-surgery.

\*Participants:

The study targets 60 patients (30 per group) who meet the following criteria:

Diagnosed with gastric adenocarcinoma and underwent curative gastrectomy (R0 resection).

Postoperative drainage of 300-500 ml/day on the 4th day after surgery. Patients with stage IV cancer, peritoneal metastasis, or postoperative complications requiring additional intervention are excluded.

\*Methods: All participants will follow standard postoperative care except for the removal or retention of the drainage tube. Follow-up will occur at 1 and 3 weeks post-discharge, with clinical examinations and imaging (if necessary) to monitor for complications such as infection or abscess. The study's total observation period will last four weeks from the surgery date.

\*Data Collection: Data will include patient demographics, surgical details, postoperative management, and the occurrence of complications. Drainage volumes will be recorded daily for those discharged with a tube, and tube removal will occur based on specific criteria.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients pathologically diagnosed with gastric adenocarcinoma before surgery.
• Patients eligible for complete surgical resection (R0 resection).
• Patients with an ASA (American Society of Anesthesiologists) score of 3 or lower.
• Patients with more than 300 ml of drainage in the 24 hours on the postoperative day 4.

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Exclusion Criteria

• Patients aged 80 or older.

• Patients with stage IV gastric cancer.

• Patients with ascites due to peritoneal metastasis.

• Patients with evident intra-abdominal complications following surgery.

• Patients who require the insertion of additional percutaneous drainage due to insufficient drainage.

• Patients who underwent incomplete gastric resection (R1 or R2 resection).

• Patients diagnosed with cancers other than gastric cancer.

• Patients with a history of major intra-abdominal surgery or abdominal radiotherapy that may hinder the normal absorption of intra-abdominal fluid.

• Patients with more than 500 ml of drainage in the 24 hours on postoperative day 4.

• Patients presenting with any of the following clinical signs or diagnoses:

  1. Postoperative pancreatic fistula (POPF), defined as drain amylase levels (Drain amylase; D-amy) more than 3 times higher than serum amylase levels (Serum amylase; S-amy).

  2. Fever exceeding 37.8℃.

  3. Presence of any of the following clinical markers of inflammation:

     i. White blood cell count (WBC) > 15,000/μL ii. C-reactive protein > 200 mg/L

  4. Observation of non-serous drainage fluid, such as:

     i. Chylous fluid: Milky-colored fluid. ii. Bloody or sanguineous fluid: Intra-abdominal fluid suggestive of ongoing hemorrhage.

• Vulnerable subjects will not be enrolled in the study, including minors, pregnant women, neonates, adults with impaired consent capacity, individuals in institutional facilities, students, employees of medical institutions or research centers, pharmaceutical company employees, military personnel, unemployed persons, impoverished individuals, homeless individuals, terminally ill patients, or patients in emergency situations.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Intra-Abdominal Complications	up to 1 month	Complications include infections, abscesses, or any clinically significant intra-abdominal issues that require medical intervention.

Secondary Outcome Measures

Name	Time	Method
Drain-Related Complications	up to 1month	The occurrence of complications related to the drainage tube in the control group, such as infection at the insertion site or mechanical issues.
CRP Level Changes	up to 1month	The comparison of C-reactive protein (CRP) level changes between the intervention and control groups during the 4-week postoperative follow-up. CRP levels will be measured to assess inflammation and potential early signs of complications.

Trial Locations

Locations (1)

Gangnam Severacne Hospital Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of